Nina Cosdon

There’s a different respiratory virus making headlines this season.

 is a common respiratory virus that typically causes mild, cold-like symptoms. While most people recover within 2 weeks, infants and older adults are susceptible to the worst of the infection.

The past couple of years, COVID-19-inspired preventative measures had the added benefit of reducing the incidence of other viruses like influenza and RSV. Now that practices like masking and social distancing are falling out of favor, we are seeing an increase in seasonal respiratory viruses.

RSV spiked early and violently this year, with infants under 6 months and adults over 65 years experiencing severe and fatal infection. “We’ve actually had summer outbreaks of RSV in the last couple of years, which is very, very unusual” said Tina Q. Tan, MD, a professor of pediatrics at Northwestern University’s Feinberg School of Medicine, medical director of the International Patient Services Program (IPS); co-director of the Pediatric Travel Medicine Clinic; and director of the International Adoptee Clinic at Ann & Robert H. Lurie Children’s Hospital of Chicago.

This year’s high rate of severe RSV infections is unprecedented, even in years before the public actively worked to lower disease transmission. The Centers for Disease Control and Prevention (CDC) 

 RSV hospitalizations for children 0-4 years of age peaked at 237.2 per 100,000 people, while hospitalizations in adults older than 65 years peaked at 17.6 per 100,000 people.

Overall hospitalizations this season peaked at 19.5 per 100000 people. For reference, the previous high was a peak of 8.8 overall hospitalizations per 100,000 people, recorded during the 2019-2020 RSV season.

“It’s just been massively out of control this year…People are acutely feeling it now due to the intensity of the peak,” said Iona M. Munjal, MD, director of clinical research and development at Pfizer.

Munjal explained that most children are exposed to RSV by the age of 5, and easily clear the virus. Now, as schools and daycares begin to open post-pandemic, large numbers of young children are experiencing severe RSV after being exposed to the virus for the first time.

RSV was first formally identified in the 1950s. Since then, Munjal said, there have not been effective solutions. “There is a single monoclonal that you give to infants that is very, very costly, and it requires a monthly injection, so it’s only given to high-risk infants.”

There is another extended duration monoclonal antibody completing phase 3 trials, which Tan called a “very promising development.” This monoclonal would be for healthy preterm and term infants, greater than 29 weeks gestation. If authorized, infants would receive a single dose of this monoclonal antibody prior to RSV season, and due to its extended duration, 1 dose would last the entire RSV season.

Of course, a high incidence rate of RSV does not mean other respiratory viruses have disappeared. Quite the opposite; fears of a confluence of RSV, influenza, and COVID-19, which some are calling a “tridemic,” are very real. “In addition to those 3 viruses,” said Tan, “there are other respiratory tract viruses that are also circulating that play into this mix.”

Unlike COVID-19 and flu, there is no approved vaccination to combat RSV. However, this could be about to change.

The COVID-19 pandemic demonstrated the rapidity with which a vaccine can be developed when there is a drastic unmet need. RSV has been circulating for decades longer than COVID-19, so why has it taken so long to get this close to the first authorized RSV vaccine?

Munjal says that the RSV virus is particularly elusive. “What's really interesting about RSV is that it comes in, it changes its shape, and then it attaches to the human host cell,” she explained. “This shape change was something we didn’t know at first.”

Tan reiterated the challenging structure of the RSV organism. She said there are a few RSV vaccines that have successfully completed phase 3 clinical trials and are going to be submitted to the US Food and Drug Administration (FDA) for licensure.

Pfizer’s bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316, accounts for the virus’s shape change. “We target the prefusion form of the virus,” said Munjal. The vaccine candidate is administered to pregnant people to help protect their infants from RSV after birth.

After sharing positive phase 3 data from the RSVpreF investigational vaccine, 

 plans to submit a Biologics License Application (BLA) to the FDA by the end of 2022.

Munjal says the fact that we are on the precipice of the first approved RSV vaccine makes it easier to talk about this season’s high incidence. “I think that when you have solutions, people are more able to talk to the problem,” Munjal commented, “because otherwise, it's frustrating.”

Tan specifically noted that the Pfizer maternal vaccine is the most promising. “The pregnant woman gets a dose of this vaccine,” she said, “and data from the phase 3 trials show that it is 82% effective preventing RSV lower tract disease in infants during the first three months of life. So it is very, very promising.”

There are other RSV vaccines on the horizon, albeit not as far along as the Pfizer maternal vaccine. “There are some RSV vaccines that are still in very early clinical trials,” said Tan. “These are intranasal RSV, vaccines that will be used in children somewhere between 6 months and 24 months of age.”

When asked why Pfizer is focused on maternal vaccination, Munjal cited its safety and efficacy. “I'm a pediatrician; if I could prevent half of the babies coming into the hospital, I would,” said Munjal. “82% [efficacy] for me is a really, really amazing achievement for the vaccine. And we're very excited.”

Munjal also noted maternal vaccination ensures high levels of antibodies are passed to infants: “We found that in some cases, moms were passing more antibodies to the baby than they kept to themselves…So relatively, they're transferring a very, very high load of antibodies to the baby.”

Respiratory viruses can be especially dangerous for pregnant people and their infants. Unfortunately, there has been an uptick in vaccine misinformation during the COVID-19 pandemic that could impact vaccinations among the most vulnerable populations.

“I think one of the biggest misconceptions is…that that moms aren't into taking vaccines,” said Munjal. “We've shown that in countries in which vaccines can be widely available, the uptick in the pregnant population is really quite good.”

Munjal emphasized that although US is experiencing a high rate of RSV in infants, these infections can be even more fatal in other nations. Therefore, the Pfizer RSV vaccine trials included a number of other countries. “Outside of the US, we have 17 other countries…we thought it was equally important to gain data in those countries.”

As previously noted, older adults are also disproportionately likely to experience severe or fatal RSV disease progression. Munjal said that Pfizer plans to submit a Biologics License Application (BLA) for both maternal and older adult populations. “The same dose that we give to pregnant women, it showed efficacy this year in older adults.”

The most common symptoms of RSV are congestion or runny nose, coughing, loss of appetite, fever or chills, sneezing, sore throat, and wheezing. While these do overlap with COVID-19 and flu symptoms, sneezing and wheezing specifically are unique to RSV.

The best way to know if one is experiencing RSV, Tan says, is to get tested, especially if the infected person is a young child or older adult. “If you have someone presenting to you that is sick enough to seek medical care, you really need to test them to determine which one of these viruses, or 

 of these viruses.” Coinfection can occur, and knowing how to treat these patients can be lifesaving.

RSV is not new, but while in the past people experiencing the virus would settle for simply calling it “a cold,” Munjal says that the severity of the COVID-19 pandemic has heightened our attention to respiratory viruses.

“I think from a pediatric perspective, I'm always struck by how prevalent the virus is,” said Munjal, noting, “almost 100% of kids have this by age 2, so you don’t get away from RSV. It’s so prevalent and so contagious that almost everyone is exposed.”

Munjal also explained why RSV is so much more deadly for infants and young children. RSV causes a large volume of fluid to build up in the lungs. While this is only mildly dangerous for adults, who have a large breathing tube, “babies are breathing through a breathing tube that's the size of a straw, and it completely fills up with fluid, and you see them struggling to breathe,” said Munjal.

“Since the 1960s, you say, ‘Oh I know your baby has RSV, and there’s nothing I can do,’” explained Munjal. An RSV vaccine would certainly be beneficial on a global level, by significantly reducing the strain on hospital resources. But Munjal noted a vaccine is also about “That really, really impactful, patient-by-patient experience…That’s the joy in this vaccine, you can finally say, ‘I have something to offer.’”

Keep up with the latest developments in RSV, vaccines, and RSV vaccines on 

Articles

Why has this season brought an unprecedented number of severe RSV infections, and why is vaccine development taking so long?

The Race to the First RSV Vaccine: How Close Are We, and Why Has It Been so Difficult?

This article was originally published in 

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on September 22 to recommend a Biologics License Application (BLA) for RBX2660 (Rebyota) to treat recurrent 

The treatment, developed by Ferring Pharmaceuticals, is aimed at reducing recurrent CDI after antibiotic usage by being administered as a pre-packaged single-dose, consisting of 150 mL microbiota suspension from individual human stool donation.

Are the available data adequate to support the effectiveness of REBYOTA to reduce the recurrence of 

 infection (CDI) in adults 18 years of age and older following antibiotic treatment for recurrent CDI?

Are the available data adequate to support the safety of REBYOTA when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI?

VRBPAC voted 13 to 4 in favor of the first question, and 12 to 4 in favor of the second, with 1 abstention.

RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic. It reduces the cycle of recurrent C diff infections by restoring the gut microbiome and inhibiting antibiotic-induced dysbiosis.

There are other treatments for patients with recurrent CDI, such as fecal microbiota transplantation (FMT). However, FMT is only recommended for patients with multiple recurrences who have also failed applicable antibiotic treatments. RBX2660 is intended to treat patients suffering from debilitating CDI, but who may not qualify for FMT.

CDI has a high rate of morbidity and mortality, in addition to draining health care resources. Approximately 500,000 Americans contract C diff each year, and 30,000 die from this highly resistant bacterium. This burden becomes greater and deadlier with each CDI recurrence.

The treatment was previously granted Fast Track, Orphan, and Breakthrough Therapy designations by the FDA. The treatment will be administered as a pre-packaged single-dose, consisting of 150 mL microbiota suspension from individual human stool donation.

, proton pump inhibitors, previous CDI, health care exposure, age above 65 years, and comorbid conditions such as malignancy, kidney disease, inflammatory bowel disease, and immunosuppression.

RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic. 

FDA Committee Recommends Approval for Live Microbiota C Difficile Medication

This article was originally published by 

 in the US, accounting for significant patient mortalities and hospital burdens. Recurrent 

 infection (rCDI) is recognized as an urgent public health threat because it's associated with even higher patient deaths.

RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic for the treatment of 

. The therapy has been evaluated in 5 prospective clinical trials. 

One study, presented at Making a Difference in Infectious Diseases (

) 2022 Annual Meeting, examined the safety and efficacy of RBX2660 as administered under US Food and Drug Administration (FDA) enforcement discretion.

Studying the Live Microbiota-Based Biotherapeutic

Data was collected from electronic health records of adult patients with rCDI for this retrospective analysis. The primary safety set included patients who had no treatment history with RBX2660, and who had continuous treatment follow-up for 6 months after receiving the therapy. 

Study outcomes of interest included safety, absence of rCDI within 8 weeks after RBX2660, and clinical response duration. A total of 94 patients were included in the study. They were enrolled from 5 sites between November 2015-September 2019. 

The most common comorbidities included gastroesophageal reflux disease (47.9%), irritable bowel syndrome (17%), gastritis (11.7%), constipation (8.5%), microscopic colitis (7.4%), diverticulitis (6.4%), Crohn’s disease (5.3%), and ulcerative colitis (4.3%). Additionally, 16% of patients were using concomitant immunosuppressants, including glucocorticoids (7%) and monoclonal antibodies (6%).

Outcomes of Clostridioides Difficile Infection (CDI) 

Of the 94 participants, 64 were in the primary safety set and were treated with RBX2660. The treatment success rate was 82.8% (

 = 53), and there was no significant difference between the patients who received 1 dose of RBX2660 (83.3%; n = 20) and the patients who received 2 doses (82.5%; n = 33).

Among those who initially responded to treatment, 88.7% (n = 47) had a sustained clinical response after 6 months. The safety outcomes were comparable to other RBX2660 studies, with 92.2% of adverse events qualified as mild-to-moderate severity. This safety profile extended to the participants with autoimmune disorders and other inflammatory conditions.

The investigators concluded that RBX2660, administered under FDA enforcement discretion, demonstrated high clinical efficacy in reducing rCDI for 6 months. These results were corroborated by other studies, and by real-world observances of the safety and efficacy of RBX2660 in patients with common rCDI comorbidities.

This study, “RBX2660, a Live Microbiota-based Biotherapeutic, Improves Outcomes of Clostridioides difficile Infection in a Real-World Population: A Retrospective Study of Use Under Enforcement Discretion,” was accepted as an abstract for the 

Making a Difference in Infectious Diseases (MAD-ID) 2022 Annual Meeting

RBX2660, an investigational microbiota-based live biotherapeutic for the treatment of C difficile, safely and effectively reduced recurrent C diff for 6 months.

Real-World Study Shows RBX2660 Improves Recurrent C Difficile Infection

There had been more 200,000 pre-exposure prophylaxis (

) initiations in North America from 2016-2020, according to data from the AIDS Vaccine Advocacy Coalition (

) earlier this year. While the US is highly contributory to the gradually increasing rate of 

-risk persons gaining access to PrEP annually, it’s not enough to consider the work accomplished on a national scale.

There are millions of untreated people that could benefit from its use, and the drivers of PrEP underutilization are multifactorial. Despite its proven benefits over the last decade, PrEP is plagued by provider challenges, limited understanding of the market for eligible patients, and prospective PrEP users’ lack of awareness of the prophylaxis therapy.

The challenge of adhering to daily oral PrEP can also pose challenges for its indicated population. Homelessness, injection drug use, and poverty are all factors that limit use. Additional demographic factors, like race, gender, and sexuality, have also been associated with challenges to PrEP uptake. For example, despite their disproportionately high HIV incidence rate, Hispanic and Latino adults were the 

 to be referred for PrEP, per a Centers for Disease Control and Prevention (CDC) study this year.

PrEP disparities are also widened by marketing tactics. Although 

heterosexuality accounts for the identified sexuality of 23% of all new HIV diagnoses annually

, HIV and AIDS are still commonly perceived to only occur among men who have sex with men (MSM), and they are the most likely to be prescribed PrEP. Lingering homophobia creates an intensely negative stigma around HIV that discourages many at-risk persons from seeking PrEP.

Because HIV is a sexually transmitted infection, 

 out of fear their family, partner, or community will view them as promiscuous. HIV is the world’s leading cause of death in women 15-49 years of age, but proportionally very few women are taking PrEP.

All these disparities in PrEP uptake and coverage have the potential to be remedied with long-lasting injectable PrEP. Cabotegravir, VIIV Healthcare’s PrEP injectable, could receive Food and Drug Administration (FDA )approval 

Dawn K. Smith, MD, MS, MPH, medical officer for the CDC noted in a statement that the FDA has set a PDUFA target date of January 24, 2022 for the new cabotegravir indictation. “(The_ CDC added a section about cabotegravir to the latest version of 

…so that providers can begin prescribing this new long-acting injectable without delay if and when it is approved,” Smith said.

If approved, cabotegravir would be the first long-acting PrEP therapy available, meaning populations unable or unwilling to adhere to a daily PrEP regimen would have an infrequent, discreet option for HIV prevention.

Suzan Walters, PhD, research assistant professor in the NYU School of Global Public Health, affiliated investigator at the 

Center for Opioid Epidemiology and Policy

, studies injection drug use and societal inequities in biomedical intervention, such as PrEP.

® that she believes it important “to offer different modalities for all drugs as people have different lives and preferences…All communities stand to benefit from injectable PrEP.”

“I do want to take a moment to express how structural conditions, such as housing and poverty create challenges not only for PrEP but for health in general,” Walters continued. “People who use drugs who also experience 

 often have challenges keeping their property, which could include PrEP, and thus injectable PrEP could mitigate this issue. There have been cases of stollen medications and as such having an option to take PrEP without the obligation to carry it around stands to benefit drug using populations, and likely many other populations.”

Walters added that drug-using populations at high HIV risk have shown capability to adhere to the demands of a daily PrEP pill, but nonetheless have expressed preference in a once-monthly injection option. For the homeless HIV-risk population, the new cabotegravir indication could have the potential to mitigate “structural burdens” associated with homelessness.

“The simple fact of having a choice in how one receives PrEP has the potential to increase uptake,” Walters said. “Choosing the best option for one’s body and lifestyle gives a patient autonomy over their healthcare journey, increasing PrEP uptake and adherence."

That said, there’s a tendency for widening treatment disparities and distribution inequities in instances when health care technological advances are reached. “We have seen this with PrEP in general, with a widening gap in uptake between white communities and communities of color,” Walters explained.

Peter Chai, MD, MMS, of the Department of Emergency Medicine and Medical Toxicology at Brigham and Women’s Hospital, Assistant Professor at Harvard Medical School, and Adjunct Faculty at The Fenway Institute, understands stigma runs deep. He was involved in the development of a digital pill for the use of studying PrEP and ART adherence. He knows PrEP can be recognized as the little blue pill, and they have been able to mask PrEP’s appearance to enable more privacy to users.

“There is this stigma of seeing the blue pill, and we can cover it and change the color to hide the fact people are on it,” Chai said. “We are very aware of stigma and stigma is a huge barrier to adherence.” This is just 1 nuanced approach to help users avoid the stigma associated with the therapy.

Jonathan Hill-Rorie, MPH, project director for our Adolescent Medicine Trials Network for HIV/AIDS Interventions, Fenway Institute, believes part of the low number of PrEP users has to do with who is getting PrEP messaging. “I think what goes on with PrEP marketing and what has gone on for the last few years has been this hyper focus on cisgender men who have sex with men (MSM) as opposed to other high-risk communities such as trans people, women who are engaging in high-risk sex,” Hill-Rorie, said. “The marketing and the way we talk about PrEP is one of the issues.”

Hill-Rorie said in addition to limited marketing, there are structural barriers including insurance challenges; general distrust of the medical community by certain communities; and the ability to obtain medications. Another element of PrEP underutilization is choice. Whereas, younger people may be less inclined to take it, older people may be more open to doing so based on their experience.

The younger generation of HIV-risk persons may not have been shaped by the historically high HIV/AIDS mortality rate and burdens observed in the early decades of the epidemic, before the advent of antiretroviral therapy (ART), Hill-Rorie explained. He pointed out that the younger generation understands the benefits of PrEP, but may not have had the same connotations associated with HIV or the benefit of time to digest the significance of taking this medication.
“Older folks in the gay community who really sing the praises of PrEP understand the importance of a medication that can prevent HIV especially given that many were around in the initial epidemic and saw lots of friends die,” Hill-Rorie explained.

Even PrEP providers are not insusceptible to the stigma surrounding HIV and PrEP. A recent 

 found that PrEP doctors’ racial stereotypes about Black women not being able or willing to adhere to a PrEP regimen prevented them from providing PrEP to this at-risk demographic.

 to prescribe PrEP to injection drug users than to other at-risk groups,. The stigma surrounding drug use is very prevalent in health care and is likely part of the reason why only 1-2% of injection drug users take PrEP.

 that prescribing PrEP to certain populations may enable them to forgo other safety measures, such as using condoms.

The CDC updated its PrEP guidelines this year, stipulating that doctors should talk to all sexually active adults about HIV PrEP, and prescribe it to any patient who asks for it. Walters emphasized the importance of doctors talking to their patients about PrEP, as increasing PrEP uptake is not possible without first increasing PrEP awareness.

“We need to scale up PrEP care across the PrEP care continuum, beginning with awareness for injectable PrEP to be a success,” Walters said.

Researchers have pointed out that it is not the role of PrEP providers to make judgements of who is “deserving” of PrEP, but rather prescribe HIV PrEP based upon available data of the groups with the highest risk of HIV infection.

“The populations I work with are often structurally disadvantaged and face severe forms of stigma, including stigma in health care,” Walters said. “In order for us to increase PrEP and in turn lower HIV incidence we really need to tackle some of the root causes of inequities. This means we need to address housing, poverty, and stigmas, including racism. It will be very hard to address HIV if we do not address the real causes of health disparities.”

HIV treatment specialist Gary Spinner, DMSc, PA, MPH, AAHIVS, is the Medical Director of the HIV/AIDS Program at Southwest Community Health Center and leads his center's initiatives on PrEP. He says he would like to see more primary care providers engaging in conversations with patients about their sexual health, which could lead to greater utilization of PrEP.

Spinner pointed out there might be just 1 PrEP prescriber in many medical settings, which means there are lost opportunities to engage many more patients in counseling on this form of HIV prevention. At Spinner’s center, they not only have a PrEP navigator to help with these conversations and get the right candidates into the treatment funnel, but there are providers across specialties at Southwest who are having PrEP conversations with patients and prescribing the therapy as well.

“One of the things I’ve really focused on is offering numerous trainings to my colleagues in primary care in my community health center, so I am no longer the sole prescriber of PrEP,” Spinner said.

How Technology Can Help People with Sexual Health

Technology is frequently used in health care field to garner greater insights about people’s behaviors, and HIV is no exception. In PrEP, investigators are looking to gain greater access to patient data, use it to serve as daily reminders, and aid in better patient outcomes.

 has been deeply involved in digital health studies and just finished recruiting for its COMPARE study, which explores the use of 2 apps to help young people better understand and manage their sexual health including possibly looking at PrEP utilization. Hill-Rorie said they are using both the My Choices and Links apps, to study people’s behaviors and that are looking at trying to help prevent HIV in young people.

In the former, the app uses quizzes and information about PrEP to educate users, and helps them make informed decisions about it. The latter app uses what Hill-Rorie said is “sex positivity” to think more critically about decisions around sex.“Those 2 apps are going to be compared to see which aspects of the 2 apps were most useful in increasing HIV and STI testing and getting folks on PrEP,” Hill-Rorie, explained.

The idea is to take the positive aspects of each of the apps and combine it into one app, so it has all these components, “to help them take ownership of the sexual health.”

Hill-Rorie said there are a multitude of ways technology can help with PrEP utilization, including who are local PrEP providers in the area, and sending daily reminders to people’s phones to make sure they are taking their medication. And although the common thought is that younger people would are more comfortable with telemedicine, Hill-Rorie said the younger generations still like to have in-person discussions.

“That is a very prevalent idea, particularly because we are in this digital era now where Gen Z is on Tick Tock, and millennials are deeply invested in Instagram and Facebook, and everything is marketed via social media,” Hill-Rorie said. “I think the knee-jerk thing is to do everything via social media and digitally. I think there are digital benefits to doing that…but I think young people are just as impacted by face-to-face and in-person interactions as well because there is a level of trust that is built when you are able to engage people one-on-one, in groups, or going into a community space and being able to talk through [things].”

Overall, clinicians have 2 PrEP challenges: the first is to get people on it; the second is to get people to stay on it.

Fenway has its LifeSteps study, which is geared towards helping people who have recently started taking PrEP, stay on their regimen. “This is an intervention where a nurse sits with a young person to talk with them about issues they are having with adhering to their medication and giving them general knowledge around sexual health,” Hill-Rorie said.

This counseling includes information on STIs and risk assessments. Over the course of 4 weeks of counseling, they can come up with strategies and solutions to overcome any barriers with PrEP adherence.

Chai has been involved in developing ingestible electronic sensor systems to understand medication adherence in the context of substance use and HIV treatment and prevention. His work in developing ingestible sensors, or “digital pills,”are being used to study behavioral interventions to measure, reinforce, and provide tools for PrEP and ART adherence. His work has been funded by the National Institutes of Health (NIH), and the sensor technology has been featured as a top innovation of 2021 by 

The digital pill is made up of a few components including a standard gel capsule, the PrEP pill itself, a radio frequency emitting device, and a wearable reader and smartphone app that lets users check their adherence. The pill and the radio frequency emitting device are placed inside the capsule. Study participants ingest the digital pill, and once it enters the stomach, acids dissolve the gel capsule. The radio frequency emitter, which is approximately the size of a sesame seed, sends a signal about 3 feet off the body that’s picked up by the wearable reader. Chai said the reader is a lanyard device that is approximately the size of an ID badge.

“There is a radio frequency transmission, and we code it to drug, time, and date. The reader sends that information to the smartphone app. Patients can look at the app and see their adherence data on demand,” Chai explained. “On the clinical side, we can also see that data and it allows us to have this interface where we can push reminders or interventions specifically around PrEP and ART adherence around individuals who are using the system.”

One of the digital pill studies Chai is working on with Fenway is the Tech PrEP Study. This specific study focuses on MSM and use substances. This study is a survey being done through use of a popular dating app. “We are trying to find out what people think about digital pills—the [aspects of them] that are really interesting to them, but also some of the pieces that are scary to them.” 

In addition, Chai said is looking to learn more about substance use and PrEP adherence. “We know from a lot of clinical trial work that most of the difficulty around PrEP adherence can come when people are using different substances because it clearly changes routines, can make people forgetful, and things like that,” Chai said. “This digital pill can reinforce the behavior of taking your PrEP despite the fact you might be taking substances.”

Another study Chai and Fenway are starting up is the PrEPsteps study. Fenway is currently recruiting people for it and their aim is to utilize an investigational smartphone-based intervention and digitized emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada) digital pill daily for 3 months to help improve adherence to PrEP.

“What we really want to know is how people are taking PrEP day-to-day,” Chai, said. “The digital pill is this marker that helps us annotate during somebody’s daily activities when they took their PrEP.”

Up to 99% effective with regular use, PrEP has significantly decreased HIV infections worldwide. But uptake and adherence remain low, especially among marginalized groups already at increased risk of contracting HIV, despite PrEP now becoming available under most healthcare plans.

Unfortunately, the deeply negative stigma surrounding HIV and HIV preventative measures augment the spread. PrEP providers and all doctors should educate their patients that HIV is not something shameful; it is an infectious disease that anyone can and does contract, but disparate incidence rates are due to societal inequities and are not intrinsic to the disease itself.

PrEP prescribers should undergo bias training to be made aware of any stereotypes they may have internalized that impede them from fairly prescribing HIV PrEP. Additionally, they should become familiar with the social factors that make certain populations more likely to develop HIV infection, and work to end disparate HIV incidence in marginalized communities.

Increased national and global HIV efforts help mitigate HIV incidence, but as one of the most effective tools available, the importance of utilizing PrEP cannot be overstated. Technological advances continue to boost the ease and accessibility of PrEP, but eradicating HIV will not be possible without first eradicating HIV stigma.

For anyone who lives in the Boston area who might be interested in participating in the PrEPsteps study, Fenway can be contacted through email at

Stigma, and a lack of communication and awareness all inhibit HIV PrEP uptake, but digital health and new forms of PrEP could boost users. 